PACKAGE LEAFLET: INFORMATION FOR THE USER. Terbinafine Aurobindo 125 mg tablets Terbinafine Aurobindo 250 mg tablets (Terbinafine)

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER Terbinafine Aurobindo 125 mg tablets Terbinafine Aurobindo 250 mg tablets (Terbinafine) Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Terbinafine Aurobindo is and what it is used for 2. Before you use Terbinafine Aurobindo 3. How to use Terbinafine Aurobindo 4. Possible side effects 5. How to store Terbinafine Aurobindo 6. Further information 1. WHAT TERBINAFINE AUROBINDO IS AND WHAT IT IS USED FOR Terbinafine Aurobindo belongs to a group of medicines called antifungals. It is used for the treatment of fungal infections of the skin (including those in between the fingers and toes) and of the nails. 2. BEFORE YOU USE TERBINAFINE AUROBINDO Do not use Terbinafine Aurobindo if you are allergic (hypersensitivity) to terbinafine or any of the other ingredients of Terbinafine Aurobindo. if you have a severe kidney problem. if you have a severe liver problem Take special care with Terbinafine Aurobindo if you have liver problems or a disease which may affect your liver. if you have psoriasis (skin disease with raised red patches of skin covered with silvery scales). if you have kidney problems. develop severe reduction in the number of white blood cells which make infections more likely (agranulocytosis) or serious illness with blistering of the skin (toxic epidermal necrolysis). You should stop taking Terbinafine Aurobindo and see your doctor immediately if you experience these side effects which are known to occur very rarely (see section 4). If any of the above warnings applies to you or has applied to you in the past, consult your doctor. Taking other medicines Please tell to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. the antibiotic, rifampicin (decreases the level of terbinafine in your blood).

2 cimetidine (a medicine for stomach ulcers and heartburn) increases the level of terbinafine in your blood. medicines used to treat depression such as clomipramine, lofepramine or paroxetine. certain medicines used to treat Parkinson s disease such as monoamine oxidase inhibitors e.g. selegiline. medicines used to treat high blood pressure or heart problems such as atenolol or carvedilol (beta blockers), oral contraceptives (the pill). Irregular periods and abnormal menstrual bleeding which may be between periods may occur in female patients. flecainide and propafenone, which are used to treat heart flutters (arrhythmias). ciclosporin (medicine used to prevent rejection of organs or tissues following a transplant or to treat certain skin conditions like psoriasis and eczema or to treat rheumatoid arthritis) tolbutamide for diabetes triazolam for relieving anxiety and/or trouble sleeping terfenadine for hay fever or other allergies Please note that the above medicines may be known to you by other names. Always thoroughly check the information leaflet of the medicines you are already using and check with your doctor or pharmacist before taking Terbinafine Aurobindo if you are taking any of the above sorts of medicines. Taking Terbinafine Aurobindo with food and drink Taking food and drink has no influence on terbinafine treatment. Pregnancy and breast-feeding If you are pregnant, think you are pregnant or are breast-feeding; you should not take Terbinafine Aurobindo unless your doctor tells you to. If you become pregnant whilst taking this medicine, you should tell your doctor as soon as possible. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Terbinafine Aurobindo should not affect your ability to drive or use machines. 3. HOW TO USE TERBINAFINE AUROBINDO Always take Terbinafine Aurobindo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Dosage Adults: The dose you are prescribed will depend on the type of infection and how bad it is. The usual dose is 250 mg Terbinafine Aurobindo daily. You should swallow your tablet whole with a glass of water. The tablets can be taken with or without food. If you suffer from kidney problems, your doctor may prescribe half the recommended dose. Duration of treatment: Your doctor will tell you how long your treatment with terbinafine will last. For general fungal skin infections, your treatment will probably last for 4 weeks. Treatment for skin infections affecting the groin or body will normally last between 2 to 4 weeks and those involving feet may last between 2 to 6 weeks.

3 For nail infections your treatment may last between 6 weeks and 3 months, although treatment for toenail infections may continue for 6 months or longer. Complete resolution of the signs and symptoms of the infection may not occur until several weeks after treatment has stopped and the infection has been cured. Children and adolescents (below 18 years of age) Terbinafine is not recommended for children and adolescents under 18 years. If you take more Terbinafine Aurobindo than you should If you or someone you know has taken more tablets than they should, consult your doctor or the nearest hospital casualty department immediately. Take this leaflet or some tablets with you so your doctor will know what you have taken.you may feel dizzy, sick and have a headache and/or stomach pain. If you forget to take Terbinafine Aurobindo If you forget to take Terbinafine Aurobindo at the right time, take them as soon as you remember. Do not take a double dose to make up for a forgotten dose. If you stop taking Terbinafine Aurobindo Do not stop taking terbinafine without consultation with your doctor, even if the infection heals. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Terbinafine Aurobindo can cause side effects, although not everybody gets them. The following side effects have been observed: You should stop taking your tablets and see your doctor immediately if you experience symptoms of angioedema / anaphylaxis, such as: - swollen face, tongue or pharynx - difficulty in swallowing - hives - difficulties in breathing - feeling faint you experience skin reactions such as weals, blisters, or a progressive rash you have abnormalities of liver function. Symptoms include yellowing of the skin, itching, unexplained and persistent nausea (feeling sick), tiredness, vomiting (being sick), dark coloured urine, light coloured stools and abdominal (tummy) pain. Very common (more than 1 in 10 patients) Joint pain (arthralgia) and muscle pain (myalgia) can occur in association with allergic skin rashes. Rash, reddening of skin with itching and hives (urticaria). If progressive skin rash occurs, the treatment must be discontinued. Common (in more than 1 in 100 patients, but less than 1 in 10 patients): Headache. Loss of appetite Stomachache, feeling of fullness, diarrhoea indigestion (dyspepsia), feeling sick (nausea). Increased hepatic enzyme levels Uncommon (in more than 1 in 1,000 patients, but less than 1 in 100 patients):

4 Loss or decrease of the sense of taste (ageusia or dysgeusia), This usually resolves slowly once you have stopped taking the medicine. Very rare cases of prolonged taste disturbances have been reported, sometimes leading to a decrease of food intake and significant weight loss. Rare (in more than 1 in 10,000 patients, but less than 1 in 1,000 patients): Incidence of allergic reactions (including anaphylaxis). Pins and needles sensation (paraesthesias), numbness (hypesthesia) and dizziness. Abnormal liver function, including liver inflammation (hepatitis) and jaundice (yellowing of the skin and eyes). Tiredness (fatigue), vague illness (malaise). Very rare (in less than 1 in 10,000 patients, including isolated reports): Reductions in the number of different types of blood cells which may increase the risk of severe infection, bleeding or may cause shortness of breath and tiredness (agranulocytosis, neutropenia, thrombocytopenia, pancytopenia). A Condition which may cause a very wide variety of symptoms such as joint pain, kidney problems, rash and fever (systemic lupus erythematosus). Anxiety and depression. Stevens-Johnson syndrome (a serious illness with blistering of the skin, mouth, eyes and genitals), Hair loss. Toxic epidermal necrolysis (a serious illness with blistering and loss of the skin), Menstrual disturbance such as abnormal menstrual bleeding which may be between periods, and an irregular cycle. Sensation of dizziness (vertigo). Serious allergic reactions, which causes swelling of the face or throat (angio odema) Increased sensitivity of your skin to sunlight. Psoriasiform eruptions or exacerbation of psoriasis. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE TERBINAFINE AUROBINDO Keep out of the reach and sight of children. Do not use Terbinafine Aurobindo after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Store in the original package in order to protect from light. Medicines should not be disposed off via wastewater or household waste. Ask your pharmacist how to dispose off medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Terbinafine Aurobindo contains The active substance is terbinafine. Each tablet contains 125 mg of terbinafine (as terbinafine hydrochloride). Each tablet contains 250 mg of terbinafine (as terbinafine hydrochloride). The other ingredients are cellulose microcrystalline, sodium starch glycolate (type A), silica colloidal anhydrous, hypromellose and magnesium steararte. What Terbinafine Aurobindo looks like and contents of the pack

5 Tablets 125 mg: White to off-white, round uncoated, biconvex bevelled edge tablets having D debossed on one side and 56 on the other side. 250 mg: White to off-white, round uncoated, biconvex bevelled edge tablets with breakline and D debossed on one side and 74 on the other side. The tablet can be divided into equal halves. Terbinafine Aurobindo tablets are available in PVC/PVDC/Aluminum blister packs of 6, 7, 8, 10, 12, 14, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, 100, 250 and 500 tablets. Not all pack sizes may be marketed. Marketing Authorization Holder Manufacturer This medicinal product is authorised in the Member States of the EEA under the following names: France: Germany: Italy: Malta: Netherlands: Poland: Spain: United Kingdom: TERBINAFINE ARROW GENERIQUES 250 mg, comprimé sécable Terbinafin Aurobindo 125/ 250 mg Tabletten Terbinafina Aurobindo Pharma Italia 250 mg compresse Terbinafine Aurobindo 125 mg/ 250mg tablets Terbinafine Aurobindo 125/ 250 mg, tabletten Terbinafine Aurobindo Terbinafina Aurobindo 250 mg comprimidos Terbinafine 250 mg tablets This leaflet was last approved in {MM/YYYY}.

6 PACKAGE LEAFLET: INFORMATION FOR THE USER Terbinafine Aurobindo 125 mg tablets Terbinafine Aurobindo 250 mg tablets (Terbinafine) Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Terbinafine Aurobindo is and what it is used for 2. Before you use Terbinafine Aurobindo 3. How to use Terbinafine Aurobindo 4. Possible side effects 5. How to store Terbinafine Aurobindo 6. Further information 1. WHAT TERBINAFINE AUROBINDO IS AND WHAT IT IS USED FOR Terbinafine Aurobindo belongs to a group of medicines called antifungals. It is used for the treatment of fungal infections of the skin (including those in between the fingers and toes) and of the nails. 2. BEFORE YOU USE TERBINAFINE AUROBINDO Do not use Terbinafine Aurobindo if you are allergic (hypersensitivity) to terbinafine or any of the other ingredients of Terbinafine Aurobindo. if you have a severe kidney problem. if you have a severe liver problem Take special care with Terbinafine Aurobindo if you have liver problems or a disease which may affect your liver. if you have psoriasis (skin disease with raised red patches of skin covered with silvery scales). if you have kidney problems. develop severe reduction in the number of white blood cells which make infections more likely (agranulocytosis) or serious illness with blistering of the skin (toxic epidermal necrolysis). You should stop taking Terbinafine Aurobindo and see your doctor immediately if you experience these side effects which are known to occur very rarely (see section 4). If any of the above warnings applies to you or has applied to you in the past, consult your doctor. Taking other medicines Please tell to your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. the antibiotic, rifampicin (decreases the level of terbinafine in your blood).

7 cimetidine (a medicine for stomach ulcers and heartburn) increases the level of terbinafine in your blood. medicines used to treat depression such as clomipramine, lofepramine or paroxetine. certain medicines used to treat Parkinson s disease such as monoamine oxidase inhibitors e.g. selegiline. medicines used to treat high blood pressure or heart problems such as atenolol or carvedilol (beta blockers), oral contraceptives (the pill). Irregular periods and abnormal menstrual bleeding which may be between periods may occur in female patients. flecainide and propafenone, which are used to treat heart flutters (arrhythmias). ciclosporin (medicine used to prevent rejection of organs or tissues following a transplant or to treat certain skin conditions like psoriasis and eczema or to treat rheumatoid arthritis) tolbutamide for diabetes triazolam for relieving anxiety and/or trouble sleeping terfenadine for hay fever or other allergies Please note that the above medicines may be known to you by other names. Always thoroughly check the information leaflet of the medicines you are already using and check with your doctor or pharmacist before taking Terbinafine Aurobindo if you are taking any of the above sorts of medicines. Taking Terbinafine Aurobindo with food and drink Taking food and drink has no influence on terbinafine treatment. Pregnancy and breast-feeding If you are pregnant, think you are pregnant or are breast-feeding; you should not take Terbinafine Aurobindo unless your doctor tells you to. If you become pregnant whilst taking this medicine, you should tell your doctor as soon as possible. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Terbinafine Aurobindo should not affect your ability to drive or use machines. 3. HOW TO USE TERBINAFINE AUROBINDO Always take Terbinafine Aurobindo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Dosage Adults: The dose you are prescribed will depend on the type of infection and how bad it is. The usual dose is 250 mg Terbinafine Aurobindo daily. You should swallow your tablet whole with a glass of water. The tablets can be taken with or without food. If you suffer from kidney problems, your doctor may prescribe half the recommended dose. Duration of treatment: Your doctor will tell you how long your treatment with terbinafine will last. For general fungal skin infections, your treatment will probably last for 4 weeks. Treatment for skin infections affecting the groin or body will normally last between 2 to 4 weeks and those involving feet may last between 2 to 6 weeks.

8 For nail infections your treatment may last between 6 weeks and 3 months, although treatment for toenail infections may continue for 6 months or longer. Complete resolution of the signs and symptoms of the infection may not occur until several weeks after treatment has stopped and the infection has been cured. Children and adolescents (below 18 years of age) Terbinafine is not recommended for children and adolescents under 18 years. If you take more Terbinafine Aurobindo than you should If you or someone you know has taken more tablets than they should, consult your doctor or the nearest hospital casualty department immediately. Take this leaflet or some tablets with you so your doctor will know what you have taken.you may feel dizzy, sick and have a headache and/or stomach pain. If you forget to take Terbinafine Aurobindo If you forget to take Terbinafine Aurobindo at the right time, take them as soon as you remember. Do not take a double dose to make up for a forgotten dose. If you stop taking Terbinafine Aurobindo Do not stop taking terbinafine without consultation with your doctor, even if the infection heals. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Terbinafine Aurobindo can cause side effects, although not everybody gets them. The following side effects have been observed: You should stop taking your tablets and see your doctor immediately if you experience symptoms of angioedema / anaphylaxis, such as: - swollen face, tongue or pharynx - difficulty in swallowing - hives - difficulties in breathing - feeling faint you experience skin reactions such as weals, blisters, or a progressive rash you have abnormalities of liver function. Symptoms include yellowing of the skin, itching, unexplained and persistent nausea (feeling sick), tiredness, vomiting (being sick), dark coloured urine, light coloured stools and abdominal (tummy) pain. Very common (more than 1 in 10 patients) Joint pain (arthralgia) and muscle pain (myalgia) can occur in association with allergic skin rashes. Rash, reddening of skin with itching and hives (urticaria). If progressive skin rash occurs, the treatment must be discontinued. Common (in more than 1 in 100 patients, but less than 1 in 10 patients): Headache. Loss of appetite Stomachache, feeling of fullness, diarrhoea indigestion (dyspepsia), feeling sick (nausea). Increased hepatic enzyme levels Uncommon (in more than 1 in 1,000 patients, but less than 1 in 100 patients):

9 Loss or decrease of the sense of taste (ageusia or dysgeusia), This usually resolves slowly once you have stopped taking the medicine. Very rare cases of prolonged taste disturbances have been reported, sometimes leading to a decrease of food intake and significant weight loss. Rare (in more than 1 in 10,000 patients, but less than 1 in 1,000 patients): Incidence of allergic reactions (including anaphylaxis). Pins and needles sensation (paraesthesias), numbness (hypesthesia) and dizziness. Abnormal liver function, including liver inflammation (hepatitis) and jaundice (yellowing of the skin and eyes). Tiredness (fatigue), vague illness (malaise). Very rare (in less than 1 in 10,000 patients, including isolated reports): Reductions in the number of different types of blood cells which may increase the risk of severe infection, bleeding or may cause shortness of breath and tiredness (agranulocytosis, neutropenia, thrombocytopenia, pancytopenia). A Condition which may cause a very wide variety of symptoms such as joint pain, kidney problems, rash and fever (systemic lupus erythematosus). Anxiety and depression. Stevens-Johnson syndrome (a serious illness with blistering of the skin, mouth, eyes and genitals), Hair loss. Toxic epidermal necrolysis (a serious illness with blistering and loss of the skin), Menstrual disturbance such as abnormal menstrual bleeding which may be between periods, and an irregular cycle. Sensation of dizziness (vertigo). Serious allergic reactions, which causes swelling of the face or throat (angio odema) Increased sensitivity of your skin to sunlight. Psoriasiform eruptions or exacerbation of psoriasis. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE TERBINAFINE AUROBINDO Keep out of the reach and sight of children. Do not use Terbinafine Aurobindo after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Store in the original package in order to protect from light. Medicines should not be disposed off via wastewater or household waste. Ask your pharmacist how to dispose off medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Terbinafine Aurobindo contains The active substance is terbinafine. Each tablet contains 125 mg of terbinafine (as terbinafine hydrochloride). Each tablet contains 250 mg of terbinafine (as terbinafine hydrochloride). The other ingredients are cellulose microcrystalline, sodium starch glycolate (type A), silica colloidal anhydrous, hypromellose and magnesium steararte. What Terbinafine Aurobindo looks like and contents of the pack

10 Tablets 125 mg: White to off-white, round uncoated, biconvex bevelled edge tablets having D debossed on one side and 56 on the other side. 250 mg: White to off-white, round uncoated, biconvex bevelled edge tablets with breakline and D debossed on one side and 74 on the other side. The tablet can be divided into equal halves. Terbinafine Aurobindo tablets are available in PVC/PVDC/Aluminum blister packs of 6, 7, 8, 10, 12, 14, 20, 28, 30, 42, 50, 56, 60, 84, 90, 98, 100, 250 and 500 tablets. Not all pack sizes may be marketed. Marketing Authorization Holder Manufacturer This medicinal product is authorised in the Member States of the EEA under the following names: France: Germany: Italy: Malta: Netherlands: Poland: Spain: United Kingdom: Terbinafine Aurobindo 125/ 250 mg compriméterbinafine ARROW GENERIQUES 250 mg, comprimé sécable Terbinafin Aurobindo 125/ 250 mg Tabletten Terbinafina Aurobindo Pharma Italia 250 mg compresse Terbinafine Aurobindo 125 mg/ 250mg tablets Terbinafine Aurobindo 125/ 250 mg, tabletten Terbinafine Aurobindo Terbinafina Aurobindo 250 mg comprimidos Terbinafine 250 mg tablets This leaflet was last approved in {MM/YYYY}.